Chantal Depondt1, Wim Van Paesschen2, Kenou van Rijckevorsel3, Iryna Leunikava4, France Ferrière5. 1. Reference Center for the Treatment of Refractory Epilepsy, Hôpital Erasme, Université Libre de Bruxelles, Route de Lennik 808, 1070, Brussels, Belgium. 2. Refractory Epilepsy Center, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. 3. Centre Hospitalier Neurologique William Lennox, Allée de Clerlande 6, 1340, Ottignies, Belgium. 4. UCB Pharma, Alfred-Nobel-Straße 10, 40789, Monheim am Rhein, Germany. 5. UCB Pharma, Allée de la Recherche 60, 1070, Brussels, Belgium. france.ferriere@ucb.com.
Abstract
BACKGROUND: New treatments are needed for patients with drug-resistant epilepsy to improve seizure control without decreasing quality of life. OBJECTIVE: In Belgium, a Medical Need Program (MNP) was initiated to make a new antiepileptic drug (brivaracetam; high-affinity synaptic vesicle protein 2A ligand) available as adjunctive therapy to treat focal seizures in patients failing treatment with three or more different antiepileptic drugs. This is a real-world chart review of the majority of patients (71%) enrolled in the MNP. PATIENTS AND METHODS: Retention and seizure outcomes of brivaracetam adjunctive treatment were evaluated in 175 patients aged ≥ 16 years enrolled in the MNP between June 2016 and May 2017 at six centers; 95.4% were previously/concomitantly treated with levetiracetam. Safety events data were also collected. RESULTS: In this highly drug-resistant population, 85.8%, 73.9%, and 64.9% of patients remained on brivaracetam, while seizure frequency decreased from baseline in 32.0%, 37.1%, and 37.3% of patients after 3, 6, and 9 months' treatment, respectively. Patients achieving 3-month seizure freedom increased from 3.2% after 3 months' treatment to 10.2% and 10.7% after 6 and 9 months' treatment, respectively. Six-month seizure freedom was achieved by 5.7% of patients at any time. Qualitative evaluation of seizures by physicians demonstrated 44.2%, 38.8%, and 43.2% of patients improved and 42.8%, 50.9%, and 50.6% remained unchanged during 3, 6, and 9 months' follow-up, respectively. No safety signals were identified. CONCLUSIONS: Retention was high during 9 months of brivaracetam treatment in drug-resistant patients, including those previously/concomitantly treated with levetiracetam; 3-month seizure freedom increased from 3.2% after 3 months to 10.7% after 9 months of treatment.
BACKGROUND: New treatments are needed for patients with drug-resistant epilepsy to improve seizure control without decreasing quality of life. OBJECTIVE: In Belgium, a Medical Need Program (MNP) was initiated to make a new antiepileptic drug (brivaracetam; high-affinity synaptic vesicle protein 2A ligand) available as adjunctive therapy to treat focal seizures in patients failing treatment with three or more different antiepileptic drugs. This is a real-world chart review of the majority of patients (71%) enrolled in the MNP. PATIENTS AND METHODS: Retention and seizure outcomes of brivaracetam adjunctive treatment were evaluated in 175 patients aged ≥ 16 years enrolled in the MNP between June 2016 and May 2017 at six centers; 95.4% were previously/concomitantly treated with levetiracetam. Safety events data were also collected. RESULTS: In this highly drug-resistant population, 85.8%, 73.9%, and 64.9% of patients remained on brivaracetam, while seizure frequency decreased from baseline in 32.0%, 37.1%, and 37.3% of patients after 3, 6, and 9 months' treatment, respectively. Patients achieving 3-month seizure freedom increased from 3.2% after 3 months' treatment to 10.2% and 10.7% after 6 and 9 months' treatment, respectively. Six-month seizure freedom was achieved by 5.7% of patients at any time. Qualitative evaluation of seizures by physicians demonstrated 44.2%, 38.8%, and 43.2% of patients improved and 42.8%, 50.9%, and 50.6% remained unchanged during 3, 6, and 9 months' follow-up, respectively. No safety signals were identified. CONCLUSIONS: Retention was high during 9 months of brivaracetam treatment in drug-resistant patients, including those previously/concomitantly treated with levetiracetam; 3-month seizure freedom increased from 3.2% after 3 months to 10.7% after 9 months of treatment.